Performance and Detection Limit Verification of Siemens Altellica IM1600 Fully Automatic Chemiluminescence Analyzer for Detecting Five Thyroid Hormones
Performance and Detection Limit Verification of Siemens Altellica IM1600 Fully Automatic Chemiluminescence Analyzer for Detecting Five Thyroid Hormones
Objective To evaluate the performance of using Siemens Altellica IM1600 fully automatic chemiluminescence analyzer to detect triiodothyronine (T3 ),thyroxine (T4 ),free triiodothyronine (FT3 ),free thyroxine (FT4 ),and thyrotropin (TSH)items.Methods Referring to the industry standards and CNAS performance verification documents,the precision,accuracy,linear range,and minimum detection limit of the Siemens Altellica IM1600 fully automatic chemiluminescence analyzer for detecting thyroid hormones were verified and evaluated.Results The intra batch precision of thyroid hormones was within 1.60％ to 4.04％,which was less than 1/4Tea (6.25％),and the inter batch precision was within 1.90％ to 8.01％,which was less than 1/3Tea (8.33％);The bias range of the five items of Jia Gong was -3.93％ to 3.70％,<1/2Tea (12.5％), which was within the allowable deviation range,and the accuracy verification was qualified;The slope of linear validation was 0.973-1.007,R2≥0.99,indicating a good linear validation;The detection limit verification of hollow white detection limit (LoB)and quantitative detection limit (LoD)both met the requirements of the manufacturer's instructions and were within the clinically acceptable range.Conclusion Siemens Altellica IM1600 fully automatic chemiluminescence analyzer can meet the requirements for detecting thyroid hormones in five aspects and is qualified for clinical diagnostic needs.
关键词
甲状腺激素5项/性能验证/检出限验证
Key words
Five thyroid function tests/Performance verification/Detection limit verification
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